20 SEPTEMBER 2007 NEW ZEALAND GAZETTE, No. 102 2763

Amendment to the Conditions of Provisional Consent to the Distributon of Medicines

Pursuant to section 23(3) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply or use in New Zealand of medicine subject to the following conditions and set out in the Schedule hereto:

Schedule

Product: Clopine
Active Ingredients: Clozapine 100mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Lincoln, Auckland

Note: This consent is given subject to the following conditions:

• The medicine may only be prescribed by:

  • registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry; and
  • medical practitioners employed as registrars in the branch of psychiatry who are under the supervision of persons of the kind referred to above.

• Persons prescribing the medicine must comply with appropriate local treatment guidelines.

• The medicine must be dispensed in accordance with appropriate local dispensing guidelines.

• Sale or marketing of this medicine may only occur if:

  • the sponsor has an appropriate blood monitoring and patient record database in place; and
  • the sponsor creates or participates in a central "red flag" database identifying patients who have previously been prescribed clozapine and who developed adverse drug reactions, which mean further use is contraindicated.

Note: This consent is valid for two years from 23 November 2006.

Product: Clopine
Active Ingredient: Clozapine 200mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Lincoln, Auckland

Note: This consent is given subject to the following conditions:

• The medicine may only be prescribed by:

  • registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry; and
  • medical practitioners employed as registrars in the branch of psychiatry who are under the supervision of persons of the kind referred to above.

• Persons prescribing the medicine must comply with appropriate local treatment guidelines.

• The medicine must be dispensed in accordance with appropriate local dispensing guidelines.

• Sale or marketing of this medicine may only occur if:

  • the sponsor has an appropriate blood monitoring and patient record database in place; and
  • the sponsor creates or participates in a central "red flag" database identifying patients who have previously been prescribed clozapine and who developed adverse drug reactions, which mean further use is contraindicated.

Note: This consent is valid for two years from 13 January 2007.

Product: Clopine
Active Ingredient: Clozapine 25mg
Dosage Form: Tablet
New Zealand Sponsor: Douglas Pharmaceuticals Limited
Manufacturer: Douglas Manufacturing Limited, Lincoln, Auckland

Note: This consent is given subject to the following conditions:

• The medicine may only be prescribed by:

  • registered medical practitioners as defined in the Health Practitioners Competence Assurance Act 2003 who are certified by the Medical Council of New Zealand as competent in the scope of practice of psychiatry; and
  • medical practitioners employed as registrars in the branch of psychiatry who are under the supervision of persons of the kind referred to above.

• Persons prescribing the medicine must comply with appropriate local treatment guidelines.

• The medicine must be dispensed in accordance with appropriate local dispensing guidelines.

• Sale or marketing of this medicine may only occur if:

  • the sponsor has an appropriate blood monitoring and patient record database in place; and
  • the sponsor creates or participates in a central "red flag" database identifying patients who have previously been prescribed clozapine and who developed adverse drug reactions, which mean further use is contraindicated.

Note: This consent is valid for two years from 23 November 2006.